Table 3.
Moderate or Severe Exacerbation Rate and Time to First Event Results in ENHANCE-1 and ENHANCE-2 Trials (mITT Population)
| Treatment Group | ENHANCE-1 |
ENHANCE-2 |
||
|---|---|---|---|---|
| Ensifentrine 3 mg BID (n = 477) | Placebo BID (n = 283) | Ensifentrine 3 mg BID (n = 498) | Placebo BID (n = 291) | |
| Moderate or severe COPD exacerbations over 24 wk | ||||
| Annualized exacerbation event rate, LS mean (95% CI) | 0.26 (0.17, 0.40) | 0.41 (0.27, 0.63) | 0.24 (0.18, 0.32) | 0.42 (0.30, 0.57) |
| Rate ratio (95% CI) | 0.64 (0.40, 1.00) | — | 0.57 (0.38, 0.87) | — |
| P value | 0.050 | — | 0.009 | — |
| Time to first event | ||||
| Log-rank test vs. placebo | P = 0.041 | — | P = 0.011 | — |
| Hazard ratio (95% CI) | 0.62 (0.39, 0.97) | — | 0.58 (0.38, 0.87) | — |
| P value | 0.038 | — | 0.009 | — |
| Moderate or severe COPD exacerbations over 48 wk | Ensifentrine (n = 280) | Placebo (n = 89) | — | — |
| Annualized exacerbation event rate, LS mean (95% CI) | 0.25 (0.13, 0.48) | 0.44 (0.22, 0.87) | — | — |
| Rate ratio (95% CI) | 0.56 (0.32, 1.00) | — | — | — |
| P value | 0.052 | — | — | — |
| Time to first event | ||||
| Log-rank test vs. placebo | P = 0.014 | — | — | — |
| Hazard ratio (95% CI) | 0.48 (0.28, 0.82) | — | — | — |
| P value | 0.007 | — | — | — |
Definition of abbreviations: BID = twice daily; CI = confidence interval; COPD = chronic obstructive pulmonary disease; LS = least squares; mITT = modified intention-to-treat.